Primary contact

ORCID ID

Contact details

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 01/07/02

Study information

Scientific title

Acronym

NACHBID

Study hypothesis

A multi-centre randomised controlled trial to recruit sufficient learning disability patients to test the null hypotheses that:1. Compared to placebo antipsychotic drugs do not reduce the incidence of aggressive behaviour in those with learning disability and challenging behaviour.2. There is no difference between the cost-effectiveness of prescribing risperidone, haloperidol or placebo in those with aggressive challenging behaviour.

Ethics approval

Study design

Primary study design

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Mental and behavioural disorders: Schizophrenia and other psychoses

Intervention

A three-arm double blind parallel design trial of placebo, haloperidol and risperidone. Block randomisation utilised with even distribution of each drug in every block, thus no gross disparity. Assessments at baseline, four weeks, twelve weeks and six months. All patients have the option of other treatments as usual during this period with the exception of any other anti-psychotic drugs.